FreeStyle Libre potential in-reader correction study
| ISRCTN | ISRCTN64992339 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64992339 |
| IRAS number | 230816 |
| Secondary identifying numbers | ADC-UK-PMS-17031 |
- Submission date
- 15/09/2017
- Registration date
- 21/09/2017
- Last edited
- 21/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Diabetes is a lifelong condition where the amount of sugar in the blood is too high. The aim of this study is to test the performance of the masked FreeStyle Libre Flash Glucose Monitoring System with and without a potential In-Reader correction, a device designed for people with diabetes to monitor their blood sugar.
Who can participate?
Patients aged 18 and over with type 1 or 2 diabetes
What does the study involve?
Participants wear two masked (blinded) sensors for up to 14 days and take at least four fingerstick blood sugar readings per day whilst wearing the sensors. Participants attend up to six visits at the clinical study site, three of the visits consist of up to 8 hours blood sampling at regular intervals.
What are the possible benefits and risks of participating?
There may be no direct benefit to the participant. The only risks of participating in this study are associated with blood sample collection. These are small but could include pain, bruising, local infection and fainting.
Where is the study run from?
BioKinetic Europe (UK)
When is the study starting and how long is it expected to run for?
September 2017 to March 2018
Who is funding the study?
Abbott Diabetes Care Ltd (UK)
Who is the main contact?
Dr Pamela Reid
Contact information
Public
Range Road
Witney
OX29 0YL
United Kingdom
Study information
| Study design | Prospective single-arm trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Effectiveness of a potential in-reader correction for FreeStyle Libre flash sensor glucose data |
| Study objectives | Assess the accuracy of the FreeStyle Libre Flash Glucose Monitoring System measured using percentage of readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL (4.4 mmol/L) and within ±20 mg/dL (1.1 mmol/L) for YSI glucose levels <80 mg/dL(4.4 mmol/L), with and without a potential In-Reader correction. |
| Ethics approval(s) | Health and Social Care Research Ethics Committee A (HSC REC A), 11/09/2017, REC ref: 17/NI/0156 |
| Health condition(s) or problem(s) studied | Diabetes mellitus |
| Intervention | Participants will wear two masked sensors for a period of up to 14 days. They will be requested to obtain at least four fingerstick readings per day whilst wearing the sensors (using the built-in test strip port in one of the study readers). Participants will have three in-clinic visits; each in-clinic visit will consist of eight hours of reference sampling at 15 minute intervals, from an IV port. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | FreeStyle Libre Flash Glucose Monitoring System |
| Primary outcome measure | The point accuracy of the FreeStyle Libre Flash Glucose Monitoring System, measured using percentage of readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL (4.4 mmol/L) and within ±20 mg/dL (1.1 mmol/L) for YSI glucose levels <80 mg/dL(4.4 mmol/L), with and without a potential In-Reader correction. Measured on days 1, 2, 5, 7, 11 and 14 of sensor wear. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 15/09/2017 |
| Completion date | 31/03/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Approximately 27 participants will be recruited |
| Total final enrolment | 27 |
| Key inclusion criteria | 1. Aged 18 years or over 2. Type 1 or type 2 diabetes requiring insulin therapy for at least 6 months prior to enrolment 3. Participant reports self-testing their blood glucose levels at least twice per day 4. Suitable venous access for study participation |
| Key exclusion criteria | 1. Have a known allergy to medical grade adhesive 2. Be pregnant or planning to become pregnant within the study duration 3. Have skin abnormality at the application sites 4. Have a pacemaker or any other neurostimulators 5. Have concomitant medical condition which in the investigator’s opinion could interfere with the study or present a risk to the safety or welfare of the participant or study staff 6. Have anaemia 7. Currently participating in another clinical study 8. Participant is unsuitable for participation due to any other cause as determined by the Investigator |
| Date of first enrolment | 18/09/2017 |
| Date of final enrolment | 28/02/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
United Kingdom
Manchester
M13 9NQ
United Kingdom
Sponsor information
Industry
Range Road
Witney
OX29 0YL
United Kingdom
"ROR" |
https://ror.org/03wnay029 |
|---|
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan as of 21/11/2024: There is no longer a plan to publish the results in a journal. Previous publication and dissemination plan: Planned publication in a peer-reviewed journal or conference presentation. Publication date January 2019. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from ADC_Witney_ClinicalAffairs@abbott.com. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No | ||
| Basic results | version 24 | 21/11/2024 | 21/11/2024 | No | No |
Additional files
Editorial Notes
21/11/2024: Basic results and total final enrolment added. Publication and dissemination plan updated.
21/12/2017: The following changes were made:
1. Recruitment end date was changed from 30/11/2017 to 28/02/2018.
2. Overall trial end date was changed from 31/12/2017 to 31/03/2018.
3. MAC Research Ltd was added as a trial participating centre.
